Clinical Trial Associate

TScan Therapeutics • Waltham, MA

2d

About The Position

Position Summary: TScan Therapeutics is a clinical-stage biotech seeking to revolutionize life-changing therapeutics for patients by identifying novel T cells and epitopes. We are looking for a Clinical Trial Associate to join our Clinical Operations team to support the execution of clinical studies across our hematological and solid tumor programs. The ideal candidate should have experience in supporting the execution of oncology clinical studies as well as a working knowledge of ICH GCP regulations. The candidate should a enjoy fast-paced, collaborative, and vibrant startup culture. A team player with a sense of urgency will thrive in this role. About TScan: TScan Therapeutics was founded in 2018 by a small group of scientists led by Dr. Stephen Elledge (Harvard Medical School/HHMI). TScan is discovering and developing novel TCR-engineered T cell therapies for the treatment of cancer. TScans discovery platform is centered around a breakthrough technology that enables the rapid, comprehensive, and genome-wide identification of the peptide antigen targets of T cell receptors. This technology greatly enhances our ability to understand the specific antigens that drive important disease processes, including tumor cell recognition by the immune system, self-reactivity in autoimmune disorders, and acquired immunity in infectious disease. TScan is using the platform in oncology to discover new TCR/target pairs and to rapidly move novel TCRs into clinical development.

Requirements

• BS in scientific or healthcare discipline with 1- 3 years experience in clinical trial management at a CRO, pharmaceutical/biotechnology company or hospital setting
• Strong computer skills, including Excel, Word, Outlook, and PowerPoint
• Knowledge of GCP guidelines and demonstrated experience supporting clinical trials
• Excellent interpersonal skills and ability to build strong professional relationships internally and externally
• Strong analytical and problem-solving skills
• Strong attention to detail in drafting materials, establishing priorities, scheduling, and meeting deadlines

Responsibilities

• Work closely with the Clinical Operations team in accordance with internal SOPs and GCP to coordinate and track study logistics, study status, enrollment, invoices, documentation, site start-up, etc
• Support the drafting and review of study-specific documents including, but not limited to, informed consent forms, regulatory documents, site training documents, etc.
• Act as a liaison and resource for external partners including CROs, vendors, investigators, and others to provide information and resolution for study requests and issues
• Work with internal supply chain and manufacturing team to place orders for manufacturing, including forecasting drug supply needs, tracking incoming leukopaks and tracking outgoing cell therapy products.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 101-250 employees